Fecal Microbiota Transplantation for Kidney Cancer

London Regional Cancer Program of the Lawson Health Research Institute, London, Canada
Kidney CancerFecal Microbiota Transplantation - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is studying if Fecal Microbiota Transplantation (FMT) can help reduce side effects from a cancer immunotherapy drug combination.

Eligible Conditions
  • Kidney Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Approximately 9 years (end of study)

28 months
Incidence of any immune-related adverse event associated with ipilimumab/nivolumab treatment
Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment
Proportion of patients who discontinue treatment because of immune-related adverse events
30 months
Health related quality of life
Approximately 7 years
Overall survival
Progression-free survival
Year 9
Objective response rate
Week 7
Assess the immune profile of the tumor
Week 10
Changes in patient microbiome following FMT
Determine the effect on immune response
Success rate of the fecal microbiota transplant

Trial Safety

Side Effects for

26%Abdominal Pain
16%Rectal Bleeding
4%Heart Burn
4%Yeast Infection
2%IBD Flare
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT03106844) in the Treatment ARM group. Side effects include: Diarrhea with 44%, Abdominal Pain with 26%, Rectal Bleeding with 16%, Constiption with 12%, Nausea with 10%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Fecal Microbiota Transplantation
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Fecal Microbiota Transplantation · No Placebo Group · Phase 1

Fecal Microbiota Transplantation
Experimental Group · 1 Intervention: Fecal Microbiota Transplantation · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 9 years (end of study)

Who is running the clinical trial?

Academic Medical Organization of Southwestern OntarioOTHER
13 Previous Clinical Trials
2,529 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
629 Previous Clinical Trials
403,957 Total Patients Enrolled
Ricardo Fernandes, MDPrincipal InvestigatorLawson Health Research Institute
1 Previous Clinical Trials
75 Total Patients Enrolled
Saman Maleki, PhDPrincipal InvestigatorLawson Health Research Institute

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can swallow capsules.
You are aware that there are risks associated with FMT (fecal microbiota transplantation) that are not related to infections, and that the long-term safety of FMT is not yet known.

Frequently Asked Questions

What is the total enrollment figure for this clinical investigation?

"Affirmative. Clinicaltrials.gov data indicates that this experiment, which was first made public on January 23rd 2020, is actively enrolling participants. 20 patients need to be enrolled at a single site." - Anonymous Online Contributor

Unverified Answer

Is there capacity available to include more participants in this research endeavor?

"Affirmative, the information available on clinicaltrials.gov indicates that a recruitment drive for this trial is underway. It was posted online on January 23rd 2020 and edited most recently in April 5th 2022; 20 volunteers are required from one single medical site." - Anonymous Online Contributor

Unverified Answer

Is Fecal Microbiota Transplantation a viable and secure therapy for patients?

"As Fecal Microbiota Transplantation is currently in its preliminary stages of research, with limited data supporting safety and efficacy; it has earned a rating of 1." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.